DECISION OF HEAD OF FOOD AND DRUG SUPERVISORY AGENCY ON COSMETICS:
In this law, the meaning of:
Cosmetics manufactured and/or distributed must comply with the following standards:
Based on materials, use, and for evaluation purpose, cosmetic products can be classified into two (2) categories:
Materials for cosmetics as set forth in Article 2 paragraph (a) must comply with quality standards in accordance with the Indonesian Cosmetic Codex or other acknowledged standards.
The materials used must comply with the following standards:
Materials, dyes, preservatives, and UV protectors, which are prohibited to be used in cosmetics, must be in accordance with those specified in Appendix 5.
Materials, which are not set forth in Articles 5 and 6, will Be further stipulated by Head of POM.
(1) Cosmetics industries must comply with the methods on how to produce good cosmetics.
(2) Industries, which have complied with methods on how to produce good cosmetics, shall be given a certificate by Head of POM.
(1) The application of methods on how to produce good cosmetics shall be done gradually in accordance with cosmetics industry's capacity.
(2) Further provisions regarding the application of methods on how to produce good cosmetics will be stipulated by Head of POM.
(1) Cosmetics before they are distributed must be registered to obtain circulation permit from Head of POM.
(2) Those who are entitled to register are:
Part Two
Procedure
(1) Application for distribution permit shall be filed in writing to Head of POM by completing registration form and disk using the established electronic registration system to perform evaluation.
(2) The evaluation into cosmetics category I is done through two (2) stages, i.e.:
(3) Evaluation into cosmetics category II may only be performed on the completeness and legality of documents.
(4) Confidentiality of the information and/or data in the application for distribution permit must be kept by Head of POM.
(1) Evaluation into the application for distribution permit shall be performed by examining the data and/or information related to quality, safety, and benefit.
(2) The evaluation specified in paragraph (1) shall be performed by the Evaluation Committee or the National Evaluation Committee established by Head of POM.
(3) Results of the evaluation set forth in paragraph (2) may be in the form of issuance of distribution permit, adding of data and/or rejection.
(4) The distribution permit set forth in paragraph (3) shall be applicable for five (5) years.
Further provisions regarding procedure of application and evaluation into distribution permit will be stipulated by the Deputy.
Every application for- distribution permit is subject to fees in accordance with the applicable laws.
(1) Cosmetics, which have obtained distribution permit, on those can be performed a re-evaluation by Head of POM.
(2) The re-evaluation as specified in paragraph (1) shall be performed if there is new data or information regarding the impact on the quality, safety, and benefit, which will have impact on public health.
The distribution permit will be withdrawn in the following events:
(1) Cosmetics packing must be able:
(2) Packing as set forth in paragraph (1) must be made in compliance with standards of safety for users and made from materials, which do not produce or yield hazardous materials or materials, which may disturb health, and must not have impact on quality.
(3) The packing cover must comply with the conditions set forth in paragraphs (1) and (2).
(1) To protect packing during distribution, the packing specified in Article 17 must be wrapped.
(2) Wrapping must be made from material, which is able to protect packing during distribution.
Packing and wrapping must be given a certification containing comprehensive, objective, information, which is not misleading.
(1) Certification must contain information, which is in accordance with the approved registration data.
(2) Certification other than the one set forth in paragraph (1) must obtain prior approval from Head of POM.
Certification of cosmetics must not contain information indicating that the cosmetics are as-if medicines.
(1) Statement or information in the certificate must be clear and readable and must be written in Latin alphabets or Arabic numbers.
(2) Certification, which is written in a foreign language, must be completed with information regarding use, methods of use, and other information in the Indonesian language.
(1) On the label affixed to the packing and/or wrapping must be contained information regarding:
(2) If all the information specified in paragraph (1) is not possible to be contained in the packing label, a hang label or a ribbon affixed to the packing or brochure may be used.
Name of product may be in the form of commonly used name or trade name.
(1) Name of manufacturer or importer/distributor must be completely written.
(2) For imported cosmetics, other than name of importer must also be written name of manufacturer.
(3) For cosmetics under license, other than name of manufacturer must also be written name of licensor.
(4) For cosmetics under contract other than name of manufacturer must also be written name of the one who grants the contract.
Producer's or importer's address must at least be completed with names of city and/or country.
(1) Size, content or net weight may be written as "netto".
(2) The term "netto" as specified in paragraph (1) must show accurately the net size or content or weight inside the packing.
(3) The statement "netto" on the cosmetics in the form of aerosol is the content and propellant.
(4) The stattement "netto" must be indicated in metric and other unit.
The writing of name of material for cosmetics must refer to the Indonesian Cosmetic Codex or other acknowledged standards.
1. Other certification on the label must be written in accordance with conditions for labelling of materials as set forth in Article 5.
2. On the supplies in the form of aerosol must be written the following reminders:
a. Caution! Avoid contact with eye and do not inhale;
b. Caution! The content is high in pressure, explode at a temperature above 500C, do not stick, do not store in a warm place, near the fire, or do not dispose in the incinerator.
Cosmetics may only be advertised after obtaining a distribution permit.
(1) The advertisement specified in Article 30 must contain:
(2) Cosmetics shall not be advertised as if they are medicines.
(3) The conditions regarding advertising will be further stipulated by Head of POM.
The giving of guidance on production, import, distribution, and use of cosmetics shall be conducted by Head of POM.
In the giving of guidance as set forth in Article 32, Head of POM may include professional organizations and relevant associations.
The giving of guidance as set forth in Article 32 shall be directed at:
(1) Supervision shall be conducted by Head of POM and it consists of performance of functions of, at least standardization, evaluation, certification, monitoring, testing, inspection, and investigation.
(2) The inspection set forth in paragraph (1) shall be performed on the activities of import, production, distribution, use, and promotion.
(3) In performing the inspection specified in paragraph (2), Head of POM may appoint an Inspector.
The inspector as specified in Article 35 paragraph (3) is authorized to:
Every person responsible for the places where inspection is conducted by the inspector is entitled to reject the inspection if the inspector does not have any identification certificate and letter of assignment of duty.
If the results of inspection performed by the inspector show assumptions or possible assumptions of criminal acts in the cosmetics field must be conducted an investigation by the investigator of the Food and Drug Supervisory Agency.
(1) Violations against the provisions of this Decision may be imposed by administrative sanctions in the form of:
(2) Other than being imposed by the administrative sanctions set forth in paragraph (1) such violations may be imposed by criminal sanctions in accordance with the applicable laws.
(1) All provisions of laws on cosmetics, which stipulation of this Decision and/or have amended, shall be applicable as long as they are not inviolation with this Decision.
(2) Cosmetics, which have obtained distribution permit and are produced prior to the stipulation of this Decision, must be adjusted to this Decision not later than one (1) year from date of stipulation of this Decision.
(1) Technical matters, which have not adequately been stipulated in this Decision, will be further set forth by the Deputy.
(2) This decision comes into full force and effect from the date of stipulation.
For public cognizance, publishing this Decision in the State Gazette of the Republic of Indonesia.
Stipulated in Jakarta
on 5 May 2003
HEAD OF THE NATIONAL AGENCY OF FOOD AND DRUG CONTROL
signed
H. SAMPURNO